Authors :
Bruno Houessou
Volume/Issue :
Volume 11 - 2026, Issue 8 - August
Google Scholar :
https://tinyurl.com/24a523ej
DOI :
https://doi.org/10.38124/ijisrt/26aug765
Note : A published paper may take 4-5
working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and
ResearchGate.
Abstract :
Investment in molecular diagnostic technologies has expanded testing capacity in resource-constrained health
systems, yet equipment availability does not necessarily translate into sustained diagnostic value. This study examines how
lifecycle management influences the performance and value realization of quantitative polymerase chain reaction (qPCR)
diagnostic assets. A mixed-methods, multi-site assessment of approximately twenty qPCR devices combined technical
inspections, environmental measurements, maintenance and operational records, diagnostic activity data, direct
observation, and stakeholder interviews. More than 3,000 diagnostic test records were examined. Although most devices
were nominally functional, effective performance varied substantially. Average utilization was approximately 40%, while
partial module failures, reagent interruptions, environmental and power constraints, reactive maintenance, fragmented
asset information, and limitations in quality assurance reduced effective diagnostic capacity. These findings indicate that
diagnostic asset performance emerges from interactions among equipment, infrastructure, users, consumables, laboratory
processes, quality systems, information, and governance rather than from technical functionality alone. The empirical
findings were interpreted against a structured review of evidence on healthcare technology management, medical equipment
lifecycle management, laboratory quality, and ISO 55000 asset-management principles. The resulting Adaptive Diagnostic
Asset Lifecycle Management Framework (ADALM) introduces the Dynamic Performance Gap (DPG) as the difference
between expected and observed asset-system performance. Identified gaps are interpreted through risk and value
considerations and translated into adaptive lifecycle decisions. ADALM establishes a line of sight between health-system
objectives, asset-management objectives, lifecycle decisions, diagnostic service performance, and health-system value. The
framework offers a context-sensitive approach for improving strategic, operational, health, economic, and environmental
performance of critical medical assets.
Keywords :
Asset Management; ISO 55000; Diagnostic Assets; qPCR; Lifecycle Management; Health Technology Management; Performance; Risk; Value Realization; LMIC.
References :
- Parsons LM, Somoskövi A, Gutierrez C, et al. Laboratory diagnosis of tuberculosis in resource-poor countries: challenges and opportunities. Clin Microbiol Rev. 2011;24(2):314–350.
- Ndlovu Z, Fajardo E, Mbofana E, et al. Multidisease testing for HIV and TB using the GeneXpert platform: a feasibility study in rural Zimbabwe. PLoS One. 2018;13(3):e0193577.
- World Health Organization. The Selection and Use of Essential In Vitro Diagnostics. Geneva: WHO; 2023.
- World Health Organization. Needs Assessment for Medical Devices. WHO Medical Device Technical Series. Geneva: WHO; 2011.
- World Health Organization. Health Technology Assessment of Medical Devices. Geneva: WHO; 2011.
- World Health Organization. Procurement Process Resource Guide. Geneva: WHO; 2011.
- World Health Organization. Introduction to Medical Equipment Inventory Management. Geneva: WHO; 2011.
- World Health Organization. Medical Equipment Maintenance Programme Overview. Geneva: WHO; 2011.
- Malkin R, Keane A. Evidence-based approach to the maintenance of laboratory and medical equipment in resource-poor settings. Med Biol Eng Comput. 2010;48(7):721–726. doi:10.1007/s11517-010-0630-1.
- Diaconu K, Chen YF, Cummins C, Jimenez Moyao G, Manaseki-Holland S, Lilford R. Methods for medical device and equipment procurement and prioritization within low- and middle-income countries: findings of a systematic literature review. Global Health. 2017;13:59. doi:10.1186/s12992-017-0280-2.
- Perry L, Malkin R. Effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? Med Biol Eng Comput. 2011;49(7):719–722. doi:10.1007/s11517-011-0786-3.
- Fonjungo PN, Kebede Y, Messele T, et al. Laboratory equipment maintenance: a critical bottleneck for strengthening health systems in sub-Saharan Africa? J Public Health Policy. 2012;33(1):34–45. doi:10.1057/jphp.2011.57.
- Marks IH, Thomas H, Bakhet M, Fitzgerald E. Medical equipment donation in low-resource settings: a review of the literature and guidelines for surgery and anaesthesia in low-income and middle-income countries. BMJ Glob Health. 2019;4:e001785. doi:10.1136/bmjgh-2019-001785.
- International Organization for Standardization. ISO 55000:2024 Asset Management—Vocabulary, Overview and Principles. Geneva: ISO; 2024.
- International Organization for Standardization. ISO 55001:2024 Asset Management—Asset Management System—Requirements. Geneva: ISO; 2024.
- International Organization for Standardization. ISO 55002:2018 Asset Management—Management Systems—Guidelines for the Application of ISO 55001. Geneva: ISO; 2018.
- International Organization for Standardization. ISO/TS 55010:2024 Asset Management—Guidance on the Alignment of Financial and Non-Financial Functions in Asset Management. Geneva: ISO; 2024.
- Webber CM, Martínez-Gálvez G, Lopera Higuita M, et al. Developing strategies for sustainable medical equipment maintenance in under-resourced settings. Ann Glob Health. 2020;86(1):39. doi:10.5334/aogh.2584.
- International Organization for Standardization. ISO 15189:2022 Medical Laboratories—Requirements for Quality and Competence. Geneva: ISO; 2022.
- Scott L, Albert H, Gilpin C, Alexander H, DeGruy K, Stevens W. Multicenter feasibility study to assess external quality assessment panels for Xpert MTB/RIF assay in South Africa. J Clin Microbiol. 2014;52(7):2493–2499. doi:10.1128/JCM.03533-13.
- Abebaw Y, Kebede A, Eshetu K, et al. Quality assurance practices in tuberculosis diagnostic health facilities in Ethiopia. PLoS One. 2022;17(6):e0269601. doi:10.1371/journal.pone.0269601.
- Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71.
- Zamzam AH, Abdul Wahab AK, Azizan MM, Satapathy SC, Lai KW, Hasikin K. A systematic review of medical equipment reliability assessment in improving the quality of healthcare services. Front Public Health. 2021;9:753951. doi:10.3389/fpubh.2021.753951.
- Oshabaheebwa S, Namuli LK, Tusabe MS, Nantume J, Ackers L, Ssekitoleko RT. Enhancing skills to promote the utilization of medical laboratory equipment in low resource settings. Health Policy Technol. 2020;9(1):94–101. doi:10.1016/j.hlpt.2020.01.001.
- Piaggio D, Castaldo R, Cinelli M, Cinelli S, Maccaro A, Pecchia L. A framework for designing medical devices resilient to low-resource settings. Global Health. 2021;17:64. doi:10.1186/s12992-021-00718-z.
- Inagaki D, Nakahara S, Chung U, Shimaoka M, Shoji K. Need for improvements in medical device management in low- and middle-income countries: applying learnings from Japan's experience. JMA J. 2023;6(2):188–191. doi:10.31662/jmaj.2022-0089.
- World Health Organization. Laboratory Quality Management System: Handbook. Geneva: WHO; 2011.
- International Organization for Standardization. ISO 17822:2020 In Vitro Diagnostic Test Systems—Nucleic Acid Amplification-Based Examination Procedures for Detection and Identification of Microbial Pathogens—Laboratory Quality Practice Guide. Geneva: ISO; 2020.
- World Health Organization. Computerized Maintenance Management System. WHO Medical Device Technical Series. Geneva: WHO; 2012.
- World Health Organization. Medical Devices: Managing the Mismatch—An Outcome of the Priority Medical Devices Project. Geneva: WHO; 2010.
- De Savigny D, Adam T, editors. Systems Thinking for Health Systems Strengthening. Geneva: Alliance for Health Policy and Systems Research, World Health Organization; 2009.
Investment in molecular diagnostic technologies has expanded testing capacity in resource-constrained health
systems, yet equipment availability does not necessarily translate into sustained diagnostic value. This study examines how
lifecycle management influences the performance and value realization of quantitative polymerase chain reaction (qPCR)
diagnostic assets. A mixed-methods, multi-site assessment of approximately twenty qPCR devices combined technical
inspections, environmental measurements, maintenance and operational records, diagnostic activity data, direct
observation, and stakeholder interviews. More than 3,000 diagnostic test records were examined. Although most devices
were nominally functional, effective performance varied substantially. Average utilization was approximately 40%, while
partial module failures, reagent interruptions, environmental and power constraints, reactive maintenance, fragmented
asset information, and limitations in quality assurance reduced effective diagnostic capacity. These findings indicate that
diagnostic asset performance emerges from interactions among equipment, infrastructure, users, consumables, laboratory
processes, quality systems, information, and governance rather than from technical functionality alone. The empirical
findings were interpreted against a structured review of evidence on healthcare technology management, medical equipment
lifecycle management, laboratory quality, and ISO 55000 asset-management principles. The resulting Adaptive Diagnostic
Asset Lifecycle Management Framework (ADALM) introduces the Dynamic Performance Gap (DPG) as the difference
between expected and observed asset-system performance. Identified gaps are interpreted through risk and value
considerations and translated into adaptive lifecycle decisions. ADALM establishes a line of sight between health-system
objectives, asset-management objectives, lifecycle decisions, diagnostic service performance, and health-system value. The
framework offers a context-sensitive approach for improving strategic, operational, health, economic, and environmental
performance of critical medical assets.
Keywords :
Asset Management; ISO 55000; Diagnostic Assets; qPCR; Lifecycle Management; Health Technology Management; Performance; Risk; Value Realization; LMIC.